Cx(Tm) Methadone(Metd) Reagent for Synchron CX Syst
FDA 510(k) K944074 · Beckman Instruments, Inc.
510(k) numberK944074
Submission
- Device name
- Cx(Tm) Methadone(Metd) Reagent for Synchron CX Syst
- Applicant
- Beckman Instruments, Inc.
Brea, CA, US - Received
- July 5, 1994
- Decision date
- December 2, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DJR – Enzyme Immunoassay, Methadone
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3620
- Specialty
- Clinical Toxicology
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| K170416 | LZI Methadone Metabolite Enzyme Immunoassay, LZI Methadone Metabolite (100 and 300)…DJR · Traditional | Lin-Zhi International, Inc. | 06/26/2017SE |
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| K151395 | Immunalysis EDDP Specific Urine Enzyme Immunoassay, Immunalysis EDDP Urine Calibrators…DJR · Traditional | Immunalysis Corporation | 07/24/2015SE |
| K151441 | First Sign Drug of Abuse Dip Card Test, First Sign Drug of Abuse Cup TestDJR · Traditional | W.H.P.M., Inc. | 06/29/2015SE |
| K131232 | Wondfo Methadone Urine Test (MTD 200), Wondofo Morphine Urine Test (Mop 100)DJR · Traditional | Guangzhou Wondfo Biotech Co., Ltd. | 05/31/2013SE |
| K092272 | Randox Methadone AssayDJR · Traditional | Randox Laboratories, Ltd. | 11/18/2010SE |
| K092258 | Randox Metabolite (Eddp) AssayDJR · Traditional | Randox Laboratories, Ltd. | 11/09/2010SE |
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Questions and answers
When was Cx(Tm) Methadone(Metd) Reagent for Synchron CX Syst cleared by the FDA?
Cx(Tm) Methadone(Metd) Reagent for Synchron CX Syst (K944074) received a 510(k) decision of Substantially Equivalent on December 2, 1994, 150 days after the submission was received.
What is the product code of K944074?
The FDA product code is DJR – Enzyme Immunoassay, Methadone, a Class II (moderate risk) device regulated under 21 CFR 862.3620.